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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Guideline study. No information about GLP compliance available. The study was conducted using skin that had been abraded (care was taken so as to only penetrate the stratum corneum and not the dermis). This deviates from the current OECD Guideline 402, however, this is not considered to affect the outcome of the study as the test material resulted in an LD50 of > 2000 mg/kg.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
This study was conducted using skin that had been abraded (care was taken so as to only penetrate the stratum corneum and not the dermis). However, this will not affect the outcome of the study.
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3,4-Thiadiazole-2(3H)-thione, 5-(tert-dodecyldithio)-
EC Number:
813-543-0
Cas Number:
73984-93-7
Molecular formula:
C14H26N2S4
IUPAC Name:
1,3,4-Thiadiazole-2(3H)-thione, 5-(tert-dodecyldithio)-
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratories, Denver, PA
- Weight at study initiation: 2.2 to 2.7 kg
- Fasting period before study: No
- Housing: Individually housed in stainless steel cages (61.0 x 45.5 x 42.0 cm)
- Diet: Rabbits were fed Purina Rabbit Chow Complete Blend (Ralston Purina Co.) ad libitum
- Water: ad libitum
- Acclimation period: 3 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 22
- Humidity (%): approx. 40 (relative)
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES:
12/3/81 – 12/18/81

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: An area of 240 cm2 on the back of each animal
- Type of wrap if used: gauze pad and plastic film covered by lint-free cloth towelling

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 0.9 % sodium chloride
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Concentration (if solution): applied undiluted
- Constant volume or concentration used: yes

Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were performed at least once a day; animals were weighed immediately prior to dosing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
No statistics reported.

Results and discussion

Preliminary study:
No preliminary study reported.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None observed.
Clinical signs:
The test site was noted to be irritated during the 14 day observation period.
Body weight:
Body weights were determined immediately prior to dosing only.
Gross pathology:
No details available.
Other findings:
Gross necropsy findings were normal

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The test report describes a valid guideline study, without information about GLP compliance. The acute dermal LD50 was determined to be > 2000 mg/kg. Thus, the test substance can be considered as not acutely toxic via the dermal route.
Executive summary:

An acute dermal study was conducted using a similar procedure to that described in the current OECD Guideline 402. The test material (CAS No. 73984 -93 -7) was applied at a dose of 2000 mg/kg to the backs of five male and five female rabbits. The substance was left in contact with the skin for 24 hours and then the test sites were washed with 0.9 % sodium chloride and the rabbits observed during this time and for 14 days after its removal. No rabbits died during the study, dermal irritation was present in all rabbits during the majority of the 14 day observation period following removal of the wrappings. Gross necropsy findings in all rabbits were within normal limits. The acute dermal LD50 was determined to be greater than 2000 mg/kg.